HELOISE Study: A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Patients With HER2-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01450696
First received: October 10, 2011
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

This randomized, open-label, multicenter, international phase IIIb study will compare the efficacy and safety of two Herceptin (trastuzumab) dosing regimens in combination with cisplatin/capecitabine chemotherapy in patients with metastatic gastric or gastro-esophageal junction adenocarcinoma. Patients who have not received prior treatment for metastatic disease will be randomized to receive Herceptin intravenously either an 8 mg/kg loading dose followed by 6 mg/kg every 3 weeks or an 8 mg/kg loading dose followed by 10 mg/kg every 3 weeks. Capecitabine will be administered for 6 cycles at a dose of 800 mg/m2 orally twice on Days 1-14 of each 3-week cycle, cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m2 on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression occurs.


Condition Intervention Phase
Gastric Cancer
Drug: capecitabine
Drug: cisplatin
Drug: trastuzumab [Herceptin]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of overall survival in patients with trastuzumab minimum concentrations Cmin <12 mcg/mL on Day 21 of Cycle 1 [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]
  • Trastuzumab minimum concentrations (Cmin) on Day 21 of Cycles 1-11 [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]
  • Progression-free survival in patients with trastuzumab Cmin <12 mcg/mL on Day 21 of Cycle 1 [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]
  • Objective response rate in patients with trastuzumab Cmin <12 mcg/mL on Day 21 of Cycle 1 [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: capecitabine
1600 mg/m2 orally daily Days 1-14 of each 3-week cycle, 6 cycles
Drug: cisplatin
80 mg/m2 iv on Day 1 of each 3-week cycle, 6 cycles
Drug: trastuzumab [Herceptin]
8 mg/kg iv loading dose, followed by 6 mg/kg iv every 3 weeks
Experimental: B Drug: capecitabine
1600 mg/m2 orally daily Days 1-14 of each 3-week cycle, 6 cycles
Drug: cisplatin
80 mg/m2 iv on Day 1 of each 3-week cycle, 6 cycles
Drug: trastuzumab [Herceptin]
8 mg/kg iv loading dose, followed by 10 mg/kg iv every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least liver or lung or both
  • Measurable disease according to RECIST 1.1 or non-measurable evaluable disease
  • At least 2 organs involved in metastatic gastric tumor (including at least lung or liver or both) in addition to the site of primary tumor. Metastasis in distant lymph nodes, peritoneal metastasis, malignant pleural effusion, etc. count as 'organs' in this context
  • HER2-positive primary or metastatic tumor
  • Adequate renal function (Creatinine clearance >/= 45 mL/min)
  • Eastern Cooperative Oncology Group (ECOG) performance status 2

Exclusion Criteria:

  • Previous chemotherapy for locally advanced or metastatic disease
  • Prior gastrectomy (partial or total) for the underlying malignant disease under investigation
  • Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
  • Residual relevant toxicity resulting from previous therapy
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with a jejunostomy probe, gastric or jejunostomy tubes which may impair the ability to administer or absorb capecitabine)
  • Current gastrointestinal bleeding
  • Other malignancy within the last 5 years, except for carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin
  • History of documented congestive heart failure; angina pectoris requiring medication; electrocardiogram (ECG) evidence of trans-mural myocardial infraction; poorly controlled hypertension; clinically significant valvular heart disease; or high risk uncontrollable arrhythmias
  • Baseline LVEF <50%, documented by echocardiography, MUGA scan, or cardiac MRI
  • Chronic high-dose corticosteroid therapy
  • History or clinical evidence of brain metastases
  • Pregnant women
  • Active infection with HIV, hepatitis B, hepatitis C, or HIV-positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450696

Contacts
Contact: Reference Study ID Number: BO27798 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, California
Terminated
La Jolla, California, United States, 92093
Terminated
Los Angeles, California, United States, 90033
Completed
Whittier, California, United States, 90603
Completed
Whittier, California, United States, 90606
United States, Indiana
Terminated
Goshen, Indiana, United States, 46526
United States, Kansas
Terminated
Wichita, Kansas, United States, 67214-3728
United States, New York
Recruiting
New York, New York, United States, 10065
United States, Oregon
Terminated
Portland, Oregon, United States, 97239
United States, South Carolina
Completed
Charleston, South Carolina, United States, 29425
Australia, New South Wales
Recruiting
Port Macquarie, New South Wales, Australia, 2444
Terminated
Wahroonga, New South Wales, Australia, 2076
Australia, South Australia
Terminated
Woodville South, South Australia, Australia, 5011
Australia, Western Australia
Recruiting
Murdoch, Western Australia, Australia, 6150
Bosnia and Herzegovina
Recruiting
Banja Luka, Bosnia and Herzegovina, 78000
Recruiting
Sarajewo, Bosnia and Herzegovina, 71000
Brazil
Not yet recruiting
Goiania, GO, Brazil, 74605-070
Active, not recruiting
Rio de Janeiro, RJ, Brazil, 20560-120
Recruiting
Porto Alegre, RS, Brazil, 90610-000
Active, not recruiting
Barretos, SP, Brazil, 14784-400
Active, not recruiting
Sao Paulo, SP, Brazil, 01246-000
Recruiting
Sorocaba, SP, Brazil, 18030-245
Chile
Terminated
Santiago, Chile, 7500921
Active, not recruiting
Santiago, Chile, 8380456
Recruiting
Viña del Mar, Chile, 2520612
China
Terminated
Beijing, China, 100853
Recruiting
Beijing, China, 100050
Recruiting
Beijing, China, 100071
Recruiting
Beijing, China, 100142
Recruiting
Changchun, China, 130012
Recruiting
Changsha, China, 410006
Not yet recruiting
Changzhou, China, 213003
Recruiting
Guangzhou, China, 510060
Recruiting
Hangzhou, China
Active, not recruiting
Nanjing, China
Recruiting
Shanghai, China, 200032
Recruiting
Wuhan, China, 430030
Recruiting
Zhengzhou, China, 450008
Czech Republic
Active, not recruiting
Brno, Czech Republic, 656 53
Active, not recruiting
Olomouc, Czech Republic, 775 20
Active, not recruiting
Praha 2, Czech Republic, 128 08
Completed
Praha 8, Czech Republic, 180 81
Germany
Recruiting
Berlin, Germany, 10117
Terminated
Frankfurt, Germany, 60488
Recruiting
Mannheim, Germany, 68167
Hungary
Recruiting
Budapest, Hungary, 1145
Terminated
Budapest, Hungary, 1097
Terminated
Pecs, Hungary, 7624
Recruiting
Szolnok, Hungary, 5004
Recruiting
Szombathely, Hungary, 9700
Terminated
Veszprem, Hungary, 8200
Italy
Terminated
Catanzaro, Calabria, Italy, 88100
Recruiting
Napoli, Campania, Italy, 80131
Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Terminated
Reggio Emilia, Emilia-Romagna, Italy, 42100
Recruiting
Udine, Friuli-Venezia Giulia, Italy, 33100
Recruiting
Milano, Lombardia, Italy, 20133
Terminated
Ancona, Marche, Italy
Recruiting
Florence, Toscana, Italy, 50124
Terminated
Pisa, Toscana, Italy, 56100
Korea, Republic of
Recruiting
Bundang City, Korea, Republic of, 463-802
Active, not recruiting
Incheon, Korea, Republic of, 405-760
Recruiting
Seoul, Korea, Republic of, 135-720
Recruiting
Seoul, Korea, Republic of, 120-749
Recruiting
Seoul, Korea, Republic of, 130-872
Recruiting
Seoul, Korea, Republic of, 135-710
Recruiting
Seoul, Korea, Republic of, 110-744
Mexico
Recruiting
Distrito Federal, Mexico, 14080
Completed
Mexico City, Mexico, 06760
Recruiting
Monterrey, Mexico, 64020
Completed
Oaxaca, Mexico, 68000
New Zealand
Recruiting
Auckland, New Zealand, 1023
Panama
Terminated
Panama, Panama, 0834-02723
Peru
Completed
Arequipa, Peru, 5154
Recruiting
Arequipa, Peru, 04001
Recruiting
Lima, Peru, Lima 41
Not yet recruiting
Lima, Peru, 34
Terminated
Lima, Peru, Lima 1
Recruiting
Lima, Peru, 1
Terminated
Trujillo, Peru, 13011
Philippines
Terminated
Manila, Philippines, 1000
Terminated
Pasig City, Philippines, 1605
Poland
Terminated
Krakow, Poland, 31-501
Active, not recruiting
Lublin, Poland, 20-090
Recruiting
Warsaw, Poland, 00-973
Recruiting
Wieliszew, Poland, 05-135
Portugal
Completed
Porto, Portugal, 4200-072
Romania
Not yet recruiting
Bucharest, Romania, 022328
Not yet recruiting
Cluj-Napoca, Romania, 400015
Not yet recruiting
Targu Mures, Romania, 540141
Russian Federation
Recruiting
Ivanovo, Russian Federation, 153040
Recruiting
Omsk, Russian Federation, 644013
Recruiting
Ryazan, Russian Federation, 390011
Recruiting
St Petersburg, Russian Federation
Recruiting
Stavropol, Russian Federation, 355045
Terminated
Tula, Russian Federation, 300053
Serbia
Recruiting
Belgrade, Serbia, 11000
Terminated
Belgrade, Serbia, 11000
Terminated
Nis, Serbia, 18000
Recruiting
Sremska Kamenica, Serbia, 21204
South Africa
Completed
Bloemfontein, South Africa, 9300
Recruiting
Cape Town, South Africa, 7506
Recruiting
Johannesburg, South Africa, 2193
Spain
Completed
Barcelona, Spain, 08041
Completed
Barcelona, Spain, 08035
Recruiting
Madrid, Spain, 28046
Turkey
Completed
Adana, Turkey, 01250
Completed
Gaziantep, Turkey, 27100
Completed
Istanbul, Turkey, 34890
Recruiting
Izmir, Turkey, 35340
Active, not recruiting
Izmir, Turkey, 35100
Not yet recruiting
Malatya, Turkey, 44280
Recruiting
Sıhhiye, ANKARA, Turkey, 06100
Ukraine
Recruiting
Cherkassy, Ukraine, 18009
Recruiting
Chernivtsi, Ukraine, 58013
Recruiting
Dnipropetrovsk, Ukraine, 49102
Active, not recruiting
Donetsk, Ukraine, 83092
Recruiting
Kiev, Ukraine, 03115
Recruiting
Lvov, Ukraine, 79031
United Kingdom
Terminated
Denbighshire, United Kingdom, LL185UJ
Terminated
Leicester, United Kingdom, LE1 5WW
Terminated
Southampton, United Kingdom, SO16 6YD
Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01450696     History of Changes
Other Study ID Numbers: BO27798, 2011-001526-19
Study First Received: October 10, 2011
Last Updated: May 11, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Capecitabine
Trastuzumab
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 28, 2015